NCT01559571已完成不适用
Study Registry for Severe Retinopathy and Treatment on Visual Outcomes of Premature Neonates
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- Pediatrix
- 入组人数
- 324
- 试验地点
- 2
- 主要终点
- Identification of visual acuity in subjects who were treated for ROP
研究概览
简要总结
The purpose of this study is to determine what factors influence the visual outcomes of infants with severe retinopathy of prematurity (ROP) and to monitor the outcomes.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- — 至 7 Days（Child）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Documentation of informed consent and authorization
- •Inborn and those admitted within 7 days of birth
- •Infant with a diagnosis of stage 2 ROP or higher
- •Site ability to plan close ophthalmological follow-up due to significant and persistent ROP
- •Parents must agree to report outcomes following each ophthalmological visit and overall outcomes for up to five (5) years of age
- •Ability to obtain follow-up data on outcomes if the child is transferred to another facility
- •No known major congenital anomalies
排除标准
- •ROP stage 1 or less
- •Parents unwilling to participate in follow-up
- •Major congenital anomalies
结局指标
主要结局
Identification of visual acuity in subjects who were treated for ROP
时间窗: Five year follow-up
次要结局
- Recurrence of stage 3+ retinopathy of prematurity in one or both eyes in zone I or posterior zone II Recurrence of stage 3+ retinopathy of prematurity in one or both eyes in zone I or posterior zone II(Five year follow-up)
研究者
研究点 (2)
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